Serialization of single-use endoscopes

ABSTRACT

A system, device and method for serializing and authorizing a single use imaging device are provided. In one embodiment, the invention provides a single use imaging device comprising a memory having a stored code that includes a unique serial identifier. In another embodiment, the invention provides a system for authorizing a single use imaging device comprising a single use imaging device with an image of a verification object that includes a serial identifier uniquely associated with the device, a control unit capable of electronically receiving the verification object image, a decoder capable of extracting a serial identifier from the verification object image, a database of authorized serial identifiers, and means for determining if the single use imaging device is authorized.

FIELD OF THE INVENTION

The present invention relates to serialization of medical devices ingeneral and single use imaging devices in particular.

BACKGROUND OF THE INVENTION

As an aid to the early detection of disease, it has become wellestablished that there are major public health benefits from regularendoscopic examinations of internal structures such as the alimentarycanals and airways, e.g., the esophagus, lungs, colon, uterus, and otherorgan systems. A conventional imaging endoscope used for such procedurescomprises a flexible tube with a fiber optic light guide that directsilluminating light from an external light source to the distal tip whereit exits the endoscope and illuminates the tissue to be examined. Anobjective lens and fiber optic imaging light guide communicating with acamera at the proximal end of the scope, or an imaging camera chip atthe distal tip, produce an image that is displayed to the examiner.

Navigation of the endoscope through complex and tortuous paths iscritical to success of the examination with minimum pain, side effects,risk or sedation to the patient. To this end, modern endoscopes includemeans for deflecting the distal tip of the scope to follow the pathwayof the structure under examination, with minimum deflection or frictionforce upon the surrounding tissue. Control cables similar to puppetstrings are carried within the endoscope body in order to connect aflexible portion of the distal end to a set of control knobs at theproximal endoscope handle. By manipulating the control knobs, theexaminer is able to steer the endoscope during insertion and direct itto a region of interest.

Conventional endoscopes are expensive medical devices costing in therange of $25,000 for an endoscope, and much more for the associatedoperator console. Because of the expense, these endoscopes are built towithstand repeated disinfections and use upon many patients.Conventional endoscopes are generally built of sturdy materials, whichdecreases the flexibility of the scope and thus can decrease patientcomfort. Furthermore, conventional endoscopes are complex and fragileinstruments that frequently need expensive repair as a result of damageduring use or during a disinfection procedure.

Single use disposable medical devices have become popular forinstruments with small lumens and intricate, delicate working mechanismsthat are difficult to sterilize or clean properly. Single use disposabledevices packaged in sterile wrappers avoid the risk of pathogeniccross-contamination of diseases such as HIV, hepatitis, and otherpathogens. Hospitals generally welcome the convenience of single usedisposable products because they no longer have to be concerned withproduct age, overuse, breakage, malfunction and sterilization. However,with the advent of single use devices comes the need for authorizationof a particular device prior to use to determine if it is new or used,that associated console software is up-to-date (e.g., sensitivity andcolor calibration tables, steering algorithms, etc.), when and where itwas manufactured, whether it is a current model, and informationregarding recall notices. Therefore, in order to prevent improper use ofsingle use devices, there is a need for a method of serializing a deviceso that prior to use, the user can be assured that the system iscurrent, all elements are compatible, and the device can be authorizedas new and unused, and ready for use.

SUMMARY OF THE INVENTION

To address these and other problems in the prior art, the presentinvention provides devices, systems and methods for serializing andauthorizing a single use medical imaging device. The device form of theinvention includes a single use imaging device having a shaft with aproximal and distal end and a connector on the proximal end forconnecting the device to a control unit. An image sensor is included ator adjacent to the distal end for producing images in a predefinedformat for receipt by an imaging board within the control unit. Thedevice includes a memory with a stored code encoding a serial identifiertransferable to the control unit for analysis, wherein the serialidentifier is uniquely associated with the imaging device at the time ofmanufacture. A transmit circuit is included that transmits the code tothe imaging board in the format of the image signals produced by theimage sensor.

In accordance with further aspects of the invention, another device formof the invention includes a control unit for authorizing a single usemedical imaging device. The control unit comprises a connector forconnecting the control unit to the single use medical imaging device anda device interface capable of receiving a code in a format of an imagesignal produced by an image sensor of the medical imaging device,wherein the code encodes a serial identifier uniquely associated withthe single use imaging device. The control unit includes a processorthat extracts the serial identifier from the code, and means fordetermining if the single use device is authorized based upon the serialidentifier associated with the device. In some embodiments, theprocessor further includes logic for calibrating the single use imagingdevice upon authorization. In some embodiments, calibration includesimaging properties and also the navigation characteristics such asdeflection ranges and sensitivities, dynamic and static, of the singleuse device. In further embodiments, the memory comprises logic forfunctionally testing the single use imaging device upon successfulcalibration.

In another aspect, the present invention provides a medical imagingsystem comprising a single use medical imaging device having an image ofa verification object encoding a serial identifier uniquely associatedwith the device and a control unit for authorizing a single use medicalimaging device. The control unit has a device interface capable ofreceiving the image of the verification object and means for determiningif the single use device is authorized based upon the serial identifierencoded in the image. In some embodiments, the verification object imageis stored in the memory of the single use device. In other embodiments,the verification object image is printed on a test target associatedwith the single use device. In some embodiments, the device isauthorized by reference to a registry contained in a remote databaseaccessible from the control unit via a network connection.

In another aspect, the present invention provides methods forauthorizing a single use imaging device. The methods of this aspect ofthe invention comprise connecting the imaging device to a control unit,electronically obtaining an image of a prerecorded verification objectassociated with the imaging device, wherein the verification objectencodes a serial identifier, extracting the serial identifier from theimage, and authorizing the imaging device by comparing the serialidentifier to a database containing information on authorized serialidentifiers. A match between the serial identifier and information inthe database results in the device being authorized for use. In someembodiments, the comparison is made to a remote database by connectingto a remote server. In some embodiments, the authentication methodfurther comprises automatic calibration and functional self-testing.

In another aspect, the present invention provides methods forserializing a set of single use imaging devices comprising assigning aunique serial identifier to each device to be manufactured, encoding theserial identifier in a verification object image, wherein theverification object image also includes a set of calibration objects,associating the verification object with each imaging device at the timeof its manufacture, and maintaining a registry of authorized serialidentifiers corresponding to manufactured serialized imaging devices,wherein a user of an imaging device may determine if the device isauthorized by comparing the serial identifier to the registry.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated as the same become betterunderstood by reference to the following detailed description, whentaken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a schematic diagram illustrative of a system for authorizing asingle use imaging device in accordance with an embodiment of thepresent invention;

FIG. 2 is a schematic diagram of an imaging system of a single useimaging device in accordance with an embodiment of the presentinvention;

FIG. 3 is a block diagram of an illustrative architecture for a controlunit for a single use imaging device in accordance with the presentinvention;

FIG. 4 illustrates the transfer of authorization data between a controlunit and a remote central server in accordance with one embodiment ofthe present invention;

FIG. 5A illustrates an embodiment of a verification object image thatencodes a serial identifier in the form of a linear bar code and a setof calibration objects;

FIG. 5B illustrates an embodiment of a verification object image thatencodes a serial identifier in the form of a two-dimensional bar codeand a set of calibration objects;

FIG. 6 is a flow diagram of a process for remotely authorizing use of asingle use medical device according to another embodiment of the methodof the invention;

FIG. 7 is a flow diagram of a process for locally authorizing use of asingle use medical device according to another embodiment of the methodof the invention;

FIG. 8 is a flow diagram of a process for authorization, calibration andself-testing in accordance with another embodiment of the presentinvention; and

FIG. 9 is a flow diagram of a process for authorization, calibration andself-testing in accordance with yet another embodiment of the presentinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Unless specifically defined herein, all terms used herein have the samemeaning as they would be understood by those of ordinary skill in theart of the present invention. The following definitions are provided inorder to provide clarity with respect to the terms as they are used inthe specification and claims to describe the present invention.

As used herein, the term “verification object image” refers to anymachine-readable image or portion thereof that is capable of encoding aserial identifier that is uniquely associated with a particular singleuse imaging device. A verification object image may include an encodedserial identifier and a set of imaging calibration objects. As usedherein, the term “serial identifier” refers to any combination orarrangement of numbers, letters, symbols, characters, colors or patternscapable of uniquely identifying a single use imaging device. Typically,a serial identifier comprises at least 10 characters and may be manymore, including possibly an Internet web address or URL. Examples ofverification object images capable of encoding serial identifiers usedin accordance with the devices, systems and methods of the inventioninclude linear bar codes and two-dimensional bar codes as furtherdescribed below.

Generally described, the present invention provides a system, device,and method for authorizing a single use imaging device prior to use.Single use imaging devices, such as endoscopes, imaging catheters, fiberoptic guide wires and the like are useful to avoid the need to sterilizeand repair complex and fragile instruments that frequently needexpensive repair as a result of damage during use or during adisinfection procedure. The devices, systems and methods of theinvention may be used to authorize single use imaging devices throughthe use of a unique serial identifier that is encoded in a verificationobject image that is associated with a single use device at the time ofmanufacture. In some embodiments, the code encoding the serialidentifier is stored in the memory of the single use device. In otherembodiments, the serial identifier is encoded in a verification objectimage that is printed on a test target that is associated with thesingle use device at the time of manufacture. In numerous embodiments, aremote central server authorizes the device. In further embodiments, theverification object is an image that includes an encoded serialidentifier and a set of imaging calibration objects.

The various embodiments of the devices, systems and methods of thepresent invention may be used by any user who would benefit fromdevices, systems and methods for authenticating an imaging device, suchas, for example, manufacturers and retailers of medical devices,physicians, surgeons, and other medical personnel, as well as patients.For example, the devices, systems and methods of the invention may beused to verify that a single use medical device is new and unused, ofcurrent production, and to further update operation parameters as wellas to obtain recall information from a remote central registry.

The detailed description is divided into six sections. In the firstsection, a brief introductory overview of the system for authorizing asingle use imaging device is provided. In the second section, a devicein the form of a single use imaging device comprising a memory with astored code encoding a serial identifier is presented. In the thirdsection, a device in the form of a control unit that interfaces with asingle use imaging device in accordance with one embodiment of theinvention is presented. In the fourth section, a medical imaging systemcomprising a single use imaging device with a verification object imageis provided. In the fifth section, a method for authorizing a single useimaging device is presented. Finally, in the sixth section, a method ofserializing single use imaging devices is described.

For ease of understanding, a brief overview of certain aspects of theexemplary authorization system 100 for a single use imaging device isillustrated by FIG. 1. The authorization system 100 includes averification object image 400 that is printed on a test target 410. Asingle use imaging device 120, such as an endoscope, comprises a shaft123 having a distal tip 122 that includes an imaging element and aproximal end 124 with a connector 128 that is attachable to a controlunit 200. Proximal to the distal tip 122 is an articulation joint 125that provides sufficient flexibility to the distal section of the shaftsuch that the distal tip 122 can be directed over the requireddeflection range (180° or more) by the steering mechanism and can bedirected to make that bend in any direction desired about thecircumference of the distal tip. In the embodiment shown, the single useimaging device 120 also includes a breakout box 126 that is positionedapproximately midway along the length of the endoscope. The breakout box126 provides an entrance to a working channel and may include additionalattachment points for collection of samples and surgical manipulation.The control unit 200 includes a device interface 210 and a networkinterface 220. The device interface 210 allows the single use imagingdevice 120 to transfer a stored code in the format of an image signal tothe control unit for analysis. While the illustrative embodiment of thesystem depicted in FIG. 1 shows an endoscope as the imaging device, itwill be understood by one skilled in the art that any type of single useimaging device can be used in accordance with the devices, systems andmethods of the invention.

FIG. 2 shows further detail of one embodiment of an imaging sensorassembly positioned at or adjacent to the distal tip 122 of an exemplarysingle use imaging device 120. The distal tip 122 includes lightillumination ports 130 and 132, an entrance to a working channel 134, acamera port 138 and a flushing cap 136. With continued reference to FIG.2, the imaging assembly includes a cylindrical lens assembly 140, and apair of LEDs 142 and 144 bonded to a circuit board 152 which is affixedto a heat exchanger 146. Fitted to the rear of the heat exchanger 146 isan image sensor 150 that preferably comprises a CMOS imaging sensor chipor other solid state imaging device. A circuit board or flex circuit 152is secured behind the image sensor 150 and contains circuitry totransmit and receive signals to and from the control unit 200. The imagesensor 150 is preferably a low light sensitive, low noise, CMOS colorimager with VGA resolution or higher such as SVGA, SXGA, or XGA. If lessresolution is required, a one-half VGA sensor could also be used. Thevideo output of the system may be in any conventional digital or analogformat, including PAL or NTSC or high definition video format. In someembodiments, the image sensor 150 comprises a VGA CMOS image sensor with640×480 active pixels and an on-chip serializer that transmits imagedata to the control cabinet in a serial form. Such a CMOS image sensoris available as Model No. MI-370 from Micron Electronics of Boise, Id.Further detail of the imaging system and its generation can be found inU.S. patent Ser. No. 10/811,781 filed Mar. 29, 2004 and which is hereinincorporated by reference.

In some embodiments of the present invention, the single use imagingdevice 120 comprises a memory having a code stored therein that encodesa serial identifier uniquely associated with the imaging device. Thecode is transferable to the control unit in the same format as imagesignals are transmitted to the control unit 200 for analysis. The memorymay be provided in the circuit board 152 and coupled to the image sensor150, or the memory may be integrated within the image sensor 150.Alternatively memory chips may also be added at, or adjacent to, theproximal end 122 of the imaging device 120. The memory can be anydigital memory which is designed to store individual bits ofinformation. Code information such as a program or data can beprogrammed into a memory chip at the time of manufacture. Codeinformation encoding a unique serial identifier or a verification objectimage embedding a code can be programmed or “burned” into the chip atthe time of manufacture. The serial identifier is in general a characterstring of sufficient length to uniquely characterize a single unit fromwithin large production runs. The identifier could be similar to thecodes used in familiar UPC barcodes (see, e.g., the Uniform CodeCouncil, Inc., Princeton Pike Corporate Center, 1009 Lenox Drive, Suite202, Lawrenceville, N.J. 08648) or more extensive codes such as webaddresses (uniform resource locators, URLs). The character string can beimpressed upon an EPROM component included in the single use-devicecamera electronics or stored at manufacture in nonvolatile memory. In apreferred embodiment of the invention, the image sensor 150 stores inits memory an image signal that contains the serial identifier used toauthorize the single use device in the same format as the medical imagesobtained during clinical use of the device.

In accordance with this aspect of the invention, the imaging device 120is capable of transferring the code containing a serial identifier inthe format of the image signals produced by the image sensor to thecontrol unit 200 for analysis. In order to transmit serial image dataand control signals along the length of the endoscope, the data andcontrol signals are preferably sent differentially along a pair oftwisted micro-coaxial cables. The stored code encoding the serialidentifier can be read as a video output signal by the control unit andused to determine if use of the imaging device is authorized.

In another aspect, the present invention provides a control unit 200 forauthorizing a single use imaging device comprising an interface that iscapable of receiving an electronic image that includes a unique serialidentifier. The code may be stored in the memory of a single use imagingdevice as described above, or, alternatively, the code may be embeddedin a verification object image that is obtained from a test targetassociated with the single use imaging device as further describedbelow.

FIG. 3 is a block diagram of an illustrative architecture for a controlunit 200 containing a computer 205 in accordance with this aspect of theinvention. Those of ordinary skill in the art will appreciate that thecomputer 205 may include additional components. However, it is notnecessary that all of these generally conventional components be shownin order to disclose an illustrative embodiment of the invention. Asshown in FIG. 3, the exemplary embodiment of the control unit 200 shownincludes a network interface 220, a processing unit 230, a deviceinterface 210, a display 240 and an image processor 242 that areconnected to the processing unit 230. The computer 205 also includes amemory 252 that stores a serial identifier database 258, an imagerecognition program 256, a calibration program 260, and an operatingsystem 262. The memory 252, display 240, network interface 220, anddevice interface 210 are all connected to the processor 230 via a bus.Other peripherals may also be connected to the processor in a similarmanner. Although the embodiment of the computer 205 shown in FIG. 3contains a calibration program 260 and a local database 258, thesefeatures are optional and not required in some embodiments of theinvention. In some embodiments of the invention, the calibration program260 interfaces with a servo motor controller (not shown) that in turncontrols a number of servo motors. Each of the servo motors is connectedto one or more control cables within the endoscope. Motion of the servomotors pulls or releases the control cables in order to change theorientation of the distal tip 122 of the imaging device 120.

Those of ordinary skill in the art will appreciate that the networkinterface 220 includes the necessary circuitry for connecting thecomputer 205 directly to a LAN or WAN, or for connecting remotely to aLAN or WAN with various communication protocols, such as the TCP/IPprotocol, the Internet Inter-ORB protocol, any of various wirelessprotocols (e.g., the IEEE 802.1x family) and the like. The deviceinterface 210 includes hardware and software components that facilitateinteraction with a device that provides an input digital image, such asan electronic image sensor (FIG. 2). The interface can receive an inputdigital signal via a wired connection, or alternatively, via a wirelesssignal from the single use imaging device. The processing unit 230 is ofsufficient power and speed to provide processing of an input digitalimage either alone or in cooperation with the image processor 242.

With continued reference to FIG. 3, the memory 252 generally comprises arandom access memory (“RAM”), a read-only memory (“ROM”) and a permanentmass storage device, such as a hard disk drive, tape driver, opticaldrive, floppy drive, CD-ROM, DVD-ROM or removable storage drive. Thememory 252 stores an operating system 262 for controlling operation ofthe computer 205.

In operation of one embodiment of the authorization system 100, uponattachment of the imaging device 120 to the control unit 200, theimaging element in the distal tip 122 of the device 120 becomesactivated and captures an image of the verification object 400 that isprinted on the test target 410 (FIG. 1). In another embodiment of theauthorization system 100, the image of verification object 400 ispre-stored in the memory of the single use device (FIG. 2) as a code atthe time of manufacture. The image of verification object 400 istransferred from the endoscope imaging element (or other memory) to thecontrol unit 200. The computer 205 and the image processor 242 receivesthe image of the verification object and extracts the serial identifierof the single use imaging device. To decode the serial number, theprocessor 230 and/or the image processor executes an image decoderprogram that detects digitized bar space patterns or other predeterminedspatial, color or numeric codes to detect the serial number.

Once the image of the verification object 400 has been decoded into theserial identifier, the authorization system 100 authorizes the devicefor use by comparing the serial identifier to a database of authorizedserial identifiers. In some embodiments, as shown in FIG. 3, the serialidentifier database 258 is stored locally in the memory 252 of thecomputer 205 contained within the control unit 200, and thedetermination is made using the recognition program 256. The database258 may be downloaded from a remote location such as from themanufacturer of the single use imaging device into the memory of thecomputer 205 via a local area network. Alternatively, periodic updatesto the serial identifier database 258 may also be provided on a CD-ROMor other machine-readable storage medium and accessible via the networkinterface 220 or by using a CD-ROM drive within the control unit 200itself. The serial number database may also include additionalinformation such as model information, product recall notices, productparameter updates, and the like.

In another embodiment of the invention, the serial number database 258is located at a remote central server that registers the use of singleuse imaging devices and marks a particular device as having been used toprevent future authorization. FIG. 4 illustrates the operation of aremote authorization system 300 to transfer authorization informationregarding a particular serial identifier between the control unit 200connected to the single use imaging device 120 and a remote centralserver 330 accessible via the Internet 320. In operation, a user may bepositioned in front of a display device 240 connected to the controlunit 200 and may initiate a request for authorization of a single useimaging device based upon the serial identifier decoded from theverification object. Alternatively, a request for authorization may beautomatically initiated by the control unit 200 via the networkinterface 220 (FIG. 1). As shown in FIG. 4, two-way communication may beinitiated by accessing the central server 330 from the control unit 200.Once a connection has been established, the control unit 200 mayconfigure the transmission of a request for authorization for aparticular serial identifier, as shown in the embodiment of system 300depicted in FIG. 4. The central server 330 receives the serialidentifier and sends an appropriate response as to whether the device isauthorized to the control unit 200 via the Internet 320. In someembodiments of the authorization system 300, the remote central servercomprises a registry that tracks usage information of single use medicaldevices.

In some embodiments of the authorization system 100, as shown in FIG. 1,the verification object image 400 is printed onto a test target 410 thatis associated with the imaging device 120 at the time of itsmanufacture. The serial identifier encoded in the verification objectimage can be any combination of letters, symbols, characters, colors orpatterns capable of uniquely identifying a single use imaging device. Aserial identifier can be encoded in any type of machine readable image,such as a linear bar code or a two-dimensional bar code as furtherdescribed below. FIGS. 5A and 5B illustrate a verification object image400A,B printed on a test target 410A,B. The verification object image400A,B includes an encoded serial identifier 420A,B that is uniquelyassociated with a single use device at time of its manufacture. In theexemplary embodiments shown in FIGS. 5A and 5B, the verification objectimages 400A,B additionally include a set of imaging calibration objects430 A-H.

In some embodiments, such as that shown in FIG. 5A, the serialidentifier is encoded in a linear bar code 420A. As shown, the exemplarylinear bar code 420A illustrated in FIG. 5A is a series of verticallines of varying widths (called bars) and spaces. Different combinationsof the bars and spaces represent different characters. To decode theserial number, the processor 230 or image processor executes a bar codereading program that detects the patterns of bars and spaces in theimage of the verification object. For example, the linear bar code 420Amay represent numeric characters only (e.g., UPC, EAN, Interleaved 2 of5), or may represent both numbers and alphabetic characters (e.g., Code93, Code 128 and Code 39).

In other embodiments, such as that shown in FIG. 5B, the serialidentifier is encoded in a two-dimensional bar code 420B. As illustratedin FIG. 5B, the two-dimensional bar code 420B stores information alongthe height as well as the length of the symbol. Illustrativenon-limiting examples of two-dimensional bar codes useful in the presentinvention include stacked bar codes, PDF417 codes, and data matrixcodes.

In a preferred embodiment, the serial identifier 420A,B of the singleuse device 120 will comply with the voluntary labeling standardsdeveloped by the Health Industry Business Communications Council(HIBCC). The HIBCC labeler identification code (LIC) primary datastructure specifies the use of either Code 128 or Code 39 symbologywhich utilize an alphanumeric character set. The 36 alpha and numericcharacters combined with the flexibility of a 1-13 digit variable lengthformat provide over 75 million trillion identifiers, thereby vastlyreducing the possibility of duplicate identifiers in the same database.HIBCC standards further specify the use of two-dimensional symbologies,such as data matrix and PDF417 for small device and instrument marking(see “The Health Industry Bar Code Supplier Labeling Standard,” AmericanNational Standards Institute, Inc. (ANSI), Health Industry BusinessCommunications Council, 2525 East Arizona Biltmore Circle, Suite 127,Phoenix, Ariz. 85016, incorporated herein by reference).

In further embodiments, the verification objects 400A,B that are printedon the test targets 410A,B include a set of calibration objects. FIGS.5A and 5B illustrate an exemplary set of calibration objects 430A-Huseful for calibrating the imaging element of the single use imagingdevice 120. Each calibration object 430A-H is positioned atpredetermined point coordinates within the verification object image.The positioning of the calibration objects 430A-H allows an imagingdevice to capture the verification object image 400A,B, and to determineif the position of the calibration objects is distorted in comparison toa pre-set standard with respect to focus, radial distortion, warping,and the like. The calibration objects 430A-H may also be positioned onvarious surfaces in order to test the motor and steering function of theimage device 120. The pre-set standard may be stored as code within thesingle use device and transmitted to the imaging board in the format ofan imaging signal as previously described. Alternatively, the pre-setstandard may be stored locally in the control unit or obtained via anetwork connection upon authorization.

The image of verification object 400A,B may be captured from the testtarget 410A,B using the imaging device 120 at various deflection anglesor focal lengths/zoom settings (if available). In operation, thecalibration objects 430A-H are compared to the pre-set standards usingthe calibration program 260. Once a distortion or other discrepancy isdetected, a set of coefficients is derived and used to perform acorrective calibration, if necessary, prior to clinical use of thedevice. In some embodiments, the verification object 400A,B contains atleast four calibration objects. In some embodiments, the verificationobject image 400A,B contains at least seven calibration objects 430A-H.In some embodiments, the identical calibration object is positioned attwo or more different predetermined locations within the verificationobject as shown in FIGS. 5A,B calibration objects 430A-H. In someembodiments, two or more calibration objects within a particularverification object image are different from one another (see FIGS. 5A,Bcalibration objects 430A and 430H). In some embodiments, a principalcalibration object may be designated in the center of the image. Inaddition, an orientation calibration object may also be designated. Inaddition to predetermined positions of the calibration objects, thepixel aspect ratio of the imaging element can be calibrated based ondetection of the pixel value of the calibration objects in order toadjust contrast, white-balance and exposure control of the imagingdevice. In some embodiments, a set of calibration objects are providedwithout a serial identifier.

The test target 410A,B can be any item upon which the verificationobject 400A,B associated with the device 120 can be printed and that isaccessible to the imaging element in the distal tip 122. For example,test target 410A,B may be printed on packaging associated with thedevice 120 or on an accessory such as a cap, cable, or other accessory.In some embodiments, the test target 410A,B is imprinted directly ontothe device 120 at a position where the image sensor can be positioned tocapture an image of the verification object.

In some embodiments, the test target 410A,B is provided on a threedimensional structure such that the calibration objects 430 A-H arepositioned at various deflection angles with respect to the position ofthe distal tip 122 of the imaging device 120. For example, a set ofcalibration objects could include targets at the corners of thespecified deflection range, which would be imaged in sequence to verifythat the navigation function is working correctly and the device can besteered, e.g., to its up/down/left/right limits. These calibrationobjects could include encoded identifiers of their location, so that theresponse to simulated user commands regarding position and transit timecan be measured, compared to quality assurance criteria, passed withrespect to acceptability thresholds (which can be tailored to individualusers and procedures) and reported to a central database.

The three dimensional positioning of the calibration objects 430 A-Hprovides objects with which to test the steering and motor functions ofthe single use imaging device 120. For example, the test target 410A,Bmay be printed on various surfaces of a hood that is placed over thedistal tip 122. As another example, the test target 410A,B may beprinted on several panels of packaging material provided with thedevice. The packaging material may be folded into various shapes, suchas a box shape to allow for image capture at various deflection angles.In such embodiments, the test targets 410A,B are positioned at anappropriate distance for the focal properties of the imaging device 120.

There are various methods of printing the verification object 400 on thetest target 410 in accordance with some embodiments of this aspect ofthe invention. In some embodiments, the printed verification objectimage contains an encoded serial identifier uniquely associated with aparticular single use device. In other embodiments, the printedverification object image contains both an encoded unique serialidentifier and a set of calibration objects. In such embodiments, theset of calibration objects are identical for a particular set ofdevices, such as a particular model of device, while the serialidentifiers are different for each device. The verification object400A,B can be printed on the test target 410A,B using labeling softwarewith a printer (dot matrix, laser or inkjet printer) and affixing theimage to the test target 410A,B, or by printing the verification objectimage 400A,B with a specialized bar code label printer. In someembodiments, verification object images in the form of data matrix canbe etched directly onto a single use device 120.

In another aspect, the present invention provides methods forauthorizing a single use imaging device. In some embodiments of thisaspect of the method of the invention, authorization is verifiedremotely. FIG. 6 is a flow chart of a process for remote authorizationusing a verification object. The remote authorization process begins at600 and comprises requesting an electronic image of the verificationobject associated with the single use device at 610, and obtaining theverification object image at 620. As indicated above, the control unitrequests the verification image after the single use device is connectedto the control unit. In some embodiments, the electronic image isobtained from the memory of the single use device. In other embodiments,the electronic image is obtained using the imaging sensor of the singleuse device. Once the machine obtains the electronic image, the image isdecoded to extract the serial identifier at 630. The machine then sendsthe serial identifier information to a remote server with anauthentication database at 640. A test is made at 650 to determine ifthe serial identifier is valid. If not, the remote server sends amessage to the user that the device is not authorized at 660, and thereis no activation. If the remote server verifies that the serialidentifier is authorized, a message is sent that the identifier is validat 650 and activation of the device is allowed at 670. The activation ofthe device triggers a message to the remote server to flag the databaseor otherwise indicate that the device has been used at 680.

The use of the remote authorization method of the invention allows aservice provider of a central server, such as a manufacturer of adevice, to maintain a registry of new authorized devices associated withunique serial identifiers and to prevent unauthorized use or reuse of adevice. Once a device is registered as used, the serial identifier isflagged or otherwise marked as having been used so that the identicalidentifier will not be authorized for future use. Using a real-timeserver logic, the authorization information can be returned to theclient. There are various suitable methods for providing userregistration and tracking of single use imaging devices, including, forexample, sending the serial identifier to a Web server application withan automatic real-time response. Upon request for verification from auser, the service provider can determine that the device is new, andalso provide important upgrades prior to unlocking features required foractivation, thus maintaining control over single use devices.

Moreover, the use of the remote authorization method allows a centralserver to verify that the client is a licensed customer, by receiving anidentification number associated with the client when the request forauthorization is made. For example, the central server may requireinformation in addition to the serial identifier such as the controlunit serial number, the client's name and location, and the like beforethe device is authorized for use.

Alternatively, in another embodiment, the invention provides a methodfor local authorization. FIG. 7 is a flow diagram of a process for localauthorization and activation using a verification object. The localauthorization process starts at 700 and comprises requesting anelectronic image of the verification object associated with the singleuse device at 710, and obtaining the verification object image 720. Oncethe control unit obtains the electronic image, the image is decoded toextract the serial identifier at 730. The control unit then obtains datafor a verification at 740 from a local database at 750. The control unitthen verifies that the serial identifier is authorized at 760 bycomparing the serial identifier to information in the database using aset of predetermined rules for authorization.

In some embodiments, the local database contains a list of authorizedserial identifiers provided by the manufacturer of the single use devicewhich may be entered into the control unit via a CD-ROM, or other formof electronic download such as a periodic Internet update. Suchauthorization data may include the serial identifiers, as well as otherinformation for updating the rules for authorization. Thus, theauthorization rules and serial identifiers may be dynamically updated sothat a control unit receives and maintains authorization rules and datathat are current. A test is made to determine if the serial identifieris valid at 770. If not, the control unit provides a message to the userat 780 that the device is not authorized, and there is no activation. Ifthe serial identifier is determined to be valid at 770, the single usedevice is authorized and activated at 790. Upon activation, the controlunit sends a message to the database at 750 to set a flag or otherwiseindicate that the device has been used at 795. This indication in thedatabase allows a user to track the usage of the single use device andto verify that any imaging device connected to the control unit is newand unused.

In some embodiments, the features used for authorization further allowthe calibration and functional self-testing of the single use imagingdevice. As shown in FIG. 8, a calibration and self-test process beginsat 800 and comprises obtaining authorization based on a valid identifierat 810 and initiating a calibration mode at 820. In the calibrationmode, calibration objects obtained from the verification object imageare compared to pre-set standards at 830. A test is made at 835 todetermine if the calibration parameters are valid. If not, a correctivecalibration is performed at 840, a new image of the verification objectis captured at 845, and the calibration objects from the most recentverification object image are compared to the pre-set standards at 830.If the parameters at 835 are determined to be valid, the control unitinitiates a functional self-test at 850. In some embodiments, theself-test parameters are updated during the authorization process.Self-test parameters may include navigation functions such as motorfunctions, steering and braking functions, transient response, positionaccuracy or error, and imaging functions like color fidelity, balance,sensitivity, linearity across a field, glare, blooming, etc. If thedevice fails the functional self-test at 850, a message is returned tothe user that the functional test failed at 860. If the device passesthe functional self-test, the single use device is activated for use at870. Upon activation, a message is sent to the database to set a flag orotherwise indicate that the device is used at 880. A correctivecalibration and functional testing may be automatically performed by thecontrol unit using predetermined algorithms, or alternatively, thesefunctions may be performed by the user utilizing user-interactivecommands.

In some embodiments, the features used for calibration allow forfunctional self-testing of the single use imaging device. As shown inFIG. 9, a calibration and functional self-test process begins at 900 andcomprises obtaining authorization based on a valid identifier at 910 andinitiating a calibration mode at 920. In the calibration mode,calibration objects obtained from the verification object image arecompared to pre-set standards at 930. A test is made at 935 to determineif the calibration parameters are valid. If not, a correctivecalibration is performed at 940, a new image of the verification objectis captured at 945, and the calibration objects from the most recentverification object image are compared to the pre-set standards at 930.If the parameters at 935 are determined to be valid, the control unitinitiates a functional self-test at 950. In the functional self-testmode, a navigation program is activated that actuates servo motorsconnected to cables inside the single use imaging device at 955. Thedistal tip of the imaging device is deflected at various angles (left,right, up, down, and the like) in order to aim at and capture an imageof each calibration object at 960. Once an image of each calibrationobject is captured, the image is compared to pre-set standards for eachlocation at 965. A test is made at 970 to determine if the devicefunctional parameters are valid. The functional parameters may includemotor functions, steering and capture of images at predeterminedlocations. If the device fails the functional self-test at 970, amessage is returned to the use that the functional test failed at 975.If the device passes the functional self-test, the single use device isactivated for use at 980. Upon activation, a message is sent to thedatabase to set a flag or otherwise indicate that the device is used at985. Those of ordinary skill in the art will recognize that thecalibration and functional self-testing functions may be accomplished ina variety of sequential steps. For example, a functional self-test maybe performed prior to or concurrent with the steps of calibration.

Although the presently preferred embodiment of the invention serializesa single use endoscope, those skilled in the art will recognize that theinvention is applicable to other single use medical imaging devices suchas catheters, imaging guide wires and the like. The methods of thisaspect of the invention comprise assigning a unique serial identifier toeach single use imaging device to be manufactured, encoding the serialidentifier in a verification object image, and associating the serialidentifier with the device at the time of manufacture. The verificationobject image may also include a set of calibration objects, therebyallowing a device to be authorized and calibrated using the samecaptured validation object image. The method further includesmaintaining a database of authorized serial identifiers corresponding tomanufactured serialized medical devices to users. In accordance withthis aspect of the invention, the user of the medical device maydetermine if a particular device is authorized by comparing the uniqueserial identifier to the database of manufactured serialized medicaldevices by utilizing the systems and methods of the invention previouslydescribed. The method of calibration using a captured validation objectmay be performed as described herein.

While the preferred embodiment of the invention has been illustrated anddescribed, it will be appreciated that various changes can be madetherein without departing from the scope of the invention. It istherefore intended that the scope of the invention be determined fromthe following claims and equivalents thereof.

1-28. (canceled)
 29. A medical imaging system comprising: an imagingdevice, comprising: a shaft with a proximal end and a distal end, animage sensor at the distal end for obtaining image data; and a targetfor viewing by the image sensor, wherein the target is uncoupled fromthe imaging device and includes one or more calibration objects.
 30. Themedical imaging system of claim 29, wherein the target includes aplurality of calibration objects positioned at predetermined locationson the target, and wherein the predetermined locations correspond topredetermined point coordinates within an image of the target obtainedby the image sensor.
 31. The medical imaging system of claim 30, whereintwo of the plurality of calibration objects are identical in form andare positioned at different locations on the target.
 32. The medicalimaging system of claim 30, wherein the plurality of calibration objectsinclude a first calibration object and a second calibration object, andwherein the first and second calibration objects have different forms.33. The medical imaging system of claim 30, wherein the plurality ofcalibration objects includes: (a) a primary calibration object at acentral section of the target, and (b) a plurality of secondarycalibration objects arranged around a periphery of the central section.34. The medical imaging system of claim 33, wherein a form of theprimary calibration object is different from forms of each of thesecondary calibration objects.
 35. The medical imaging system of claim30, wherein at least two of the plurality of calibration objects areangled relative to each other.
 36. A medical imaging system comprising:an imaging device, comprising: a shaft with a proximal end and a distalend, and an image sensor at the distal end for obtaining image data; anda target for viewing by the image sensor, wherein the target is moveablerelative to the imaging device and includes a plurality of test objects,and wherein the image sensor is configured to receive image dataindicative of the plurality of test objects from the target as the imagesensor is deflected to a plurality of positions relative to the target.37. The medical imaging system of claim 36, wherein at least two of theplurality of test objects are angled relative to each other.
 38. Themedical imaging system of claim 56, wherein the imaging device furthercomprises a steering assembly comprising of one or more motors and oneor more cables for steering the distal end of the shaft to deflect theimage sensor.
 39. The medical imaging system of claim 56, wherein theplurality of test objects are positioned at predetermined locations onthe target, and wherein the predetermined locations correspond topredetermined point coordinates within an image of the target obtainedby the image sensor.
 40. The medical imaging system of claim 56, whereinat least two of the plurality of test objects have the same form.
 41. Anobject for viewing by an image sensor of a medical imaging device, theobject comprising: a target uncoupled from the medical imaging device;and a first verification object on the target, the first verificationobject being uniquely associated with the medical imaging device. 42.The target of claim 41, further comprising a second verification objecton the target, wherein the second verification object is different fromthe first verification object.
 43. The target of claim 41, wherein thefirst verification object comprises a serial identifier encoded withinthe first verification object.
 44. The target of claim 41, wherein thefirst verification object is a three-dimensional object.
 45. The targetof claim 41, wherein the first verification object comprises a patternof at least two bars and at least one space, wherein the at least twobars and at least one space represents at least one of numericcharacters or alphabetic characters.
 46. The target of claim 41, whereinthe first verification object comprises an image, wherein the imagefurther comprises a calibration object positioned at predetermined pointcoordinates within the image.
 47. The target of claim 41, wherein thefirst verification object comprises a set of calibration objects,wherein the set of calibration objects permits the use of a device. 48.The target of claim 41, further comprising a second verification objecton the target, wherein the first verification object and the secondverification are identical in form and are positioned at differentlocations on the target.